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Position : Senior Manager - Corporate Quality Policies and Standards

Department : Corporate Quality Policies, Training and Communication

Location : Baroda, India

Reporting Manager : Head, Corporate Quality Policies and Standards

Responsible for working within the Corporate Documentation Matrix team, influencing process, tool and template improvement, helping to facilitate alignment across multiple Functional Manuals. Author documents such as Global Policies, Global Quality Standards, and Global SOPs in partnership with functional area subject matter experts and Business Co-owners ensuring these global documents are written to a comprehensive level, and agreed upon by key stakeholders. Additionally this role will ensure all documents authored are aligned to compendial, ICH and FDA and other regulatory guidance expectations.

This individual will work independently, and manage multiple assignments simultaneously with Business Co-owner and functional Key SMEs. Ensures all written documents conform to an approved document format, standards, style, and terminology. Works within Sun Pharmas EDMS system to ensure proper workflows are utilized with appropriate review and approval.

Responsibilities include:

• Author and fully manage the lifecycle (development, review, change control, execution, approval, effective status, training activities, revision, obsoletion etc.) of the following global document types:

• Global Quality Manual (GQM)

• Global Quality Policy (GPOLs)

• Global Quality Standard (GQSs)

• Global Standard Operating Procedure (GSOPs)

• Global Form (GF)

• Global Quality System User Manual (GSUM)

• Function as the SME on the applicable Health Agency Regulations and best industry practices

• Keep abreast of updates to applicable Health Agency Regulations, develop and maintain regulatory requirements trackers

• Provide technical and regulatory guidance w.r.t. global regulations to internal and external stake-holders to ensure overall quality and compliance

• Develop and maintain effective relationships with appointed Business Co-Owners and Reviewers

• Support site deployment and implementation process sustainability and effectiveness

• Perform periodic assessment of GPOLs/GQSs/GSOPs regarding: implementation feedback; status based on sites input; corporate audit observations; site self-inspections outcomes; regulatory inspections and updates to regulatory requirements

• Work with Corporate Training team on Quality Training and Certification Programs as SME within applicable areas of expertise

• Train personnel on specific areas of expertise and provide input into development of training courses and programs

• Work with the Corporate Audit Department on the annual plan for Verification Audits of Global sites, and represent corporate management supporting the Site Verification Audit as the Global Documentation SME

• Provide input to departmental dashboards that illustrate progress and effectiveness of ongoing development activities

• Act as a contributing member of the global SPOCs forum, ensuring consistent approaches to document development and site implementation as appropriate

• Manage technical writing issues, identify and manage risks and deliverables

• Effectively facilitate discussions to attain consensus between business stakeholders

• Define process strategy and success criteria

• Work directly with the cross functional team members/ their team leaders to estimate effort, plan activities and negotiate consensus among individual team members on their appointed tasks

• Develop and manage global document implementation packages; request and review site gap assessment forms when necessary

• Conduct periodic meetings to ensure transparency of activities, and assure lessons learned are captured for future use

• Support regulatory audit preparation and execution of global sites by travelling to the facility location

Education Requirement

• Bachelor's degree (BA/BS) in Life Sciences, Pharmacy, or equivalent required, with an MA preferred.

Experience Requirement

• Minimum 7 10 years of progressive experience within the pharmaceutical industry in QC or QA management roles.

• At least 5 years of SOP writing experience, preferably at the global level

• Sound knowledge of Health Canada, FDA and other global pharmaceutical regulations.

• Thorough understanding of GMPs, specifically those relating to good documentation practices.

• Ability to work effectively in an international multicultural matrix organization.

• TrackWise system knowledge is an asset.

• Knowledge of global project management principles, practices, techniques and tools; demonstrated ability to effectively manage global level projects with proven ability to meet strict timelines.

• Broad understanding of drug development, manufacturing processes, and quality.

• Strong communication, interpersonal and organizational skills.

Additional Skills

• Project Management experience

• Excellent written and verbal skills

• Technical expertise with SharePoint, MS Office, and EDMS (Documentum)

• Ability to work independently, take initiative and lead, inspire and motivate a team

• Strong interpersonal skills

Candidate should be ok to travel internationally.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.